Jude Medical Prosthesis Research Articles

Aortic valve replacement with the St. Jude Medical prosthesis and fixed dose anticoagulation.

Over a 10-year period, between 1986 and 1996, 865 patients underwent primary aortic valve replacement (AVR) with the St. Jude Medical mechanical prosthesis. Patients who had undergone valve replacement with a different type of prosthesis previously were excluded from this study. Patient age ranged from 11 to 79 years. The mean age was 42.9 +/- 14.54. The gender distribution was 396 men (45.8%) and 469 women (54.2%). All patients received 2.5 mg/day Coumadin after extubation. A combination of the antiaggregant therapy (Dypridamole 3X 75 mg/day, Asprine 100 mg/day) was added after removal of the chest tubes. The dosage of Coumadin was maintained constant regardless of the prothrombin time (PT) or cardiac rhythm. There were 101 valve-related complications (4.2% per patient year [ppy]) occurring in the late follow-up period. Of these complications; 38 were anticoagulant-related hemorrhage (1.58% ppy), 3 were paravalvular leak (0.12% ppy), and 36 were thromboembolism (1.4% ppy). There were 24 reoperations (0.99% ppy) and 17 late deaths. The linearized late mortality rate was 0.7% ppy. Long-term survival estimates at 5 and 10 years were 97.14 +/- 0.82% and 94.86 +/- 1.54%, respectively. We conclude from the data that the St. Jude Medical valve may allow the use of a low level of anticoagulation. This study shows that fixed dose oral anticoagulation does not increase the rate of thromboembolism in patients with the St. Jude aortic valve. This protocol does not result in reduction of bleeding complications, however.

Minimally invasive mitral valve replacement: Port-access technique, feasibility, and myocardial functional preservation

Objective: This experiment examined the feasibility of minimally invasive port-access mitral valve replacement via a 2.5 cm incision. Methods: The study evaluated valvular performance and myocardial functional recovery in six mongrel dogs after port-access mitral valve replacement with a St. Jude Medical prosthesis (St. Jude Medical, Inc., St. Paul, Minn.). Femoro-femoral cardiopulmonary bypass and a balloon catheter system for myocardial protection with cardioplegic arrest (Heartport, Inc., Redwood City, Calif.) were used. The mitral valve was replaced through a 2.5 cm port in the left side of the chest, and the animals were weaned from bypass. Cardiac function was measured before and at 30 and 60 minutes after bypass. Left ventricular pressure and electrical conductance volume were used to calculate changes in load-independent indexes of ventricular function. Results: Each procedure was successfully completed. Recovery of left ventricular function was excellent at 30 and 60 minutes after bypass compared with the prebypass values for elastance (30 minutes = 4.04 ± 0.97 and 60 minutes = 4.27 ± 0.57 vs prebypass = 4.45 ± 0.96; p = 0.51) and for preload recruitable stroke work (30 minutes = 76.23 ± 4.80 and 60 minutes = 71.21 ± 2.99 vs prebypass = 71.23 ± 3.75; p = 0.45). Preload recruitable work area remained at 96% and 85% of baseline at 30 and 60 minutes ( p = not significant). In addition, transesophageal echocardiography demonstrated normal prosthetic valve function, as well as normal regional and global ventricular wall motion. Autopsy revealed secure annular-sewing apposition and normal leaflet motion. Conclusions: These results suggest that minimally invasive mitral valve replacement using percutaneous cardiopulmonary bypass with cardioplegic arrest is technically reproducible, achieves normal valve placement, and results in complete cardiac functional recovery. Minimally invasive mitral valve replacement is now feasible, and clinical trials are indicated. (J Thorac Cardiovasc Surg 1997; 113:1022-31)

St. Jude medical valve prosthesis: An analysis of long-term outcome and prognostic factors

Between 1979 and 1984, 321 patients received 354 St. Jude Medical prostheses (194 aortic, 94 mitral, 1 tricuspid, and 32 multiple valve replacements). Follow-up was 96% complete (2967 patient-years; mean 9.5 years per patient). Actuarial event-free rates at 10 years and linearized rates (in parentheses) of late complications were as follows: embolism, 85.0% ± 2.3% (2.3% per patient-year); anticoagulant-related hemorrhage, 74.8% ± 2.7% (3.3% per patient-year); cerebrovascular accident, 81.8% ± 2.5% (2.6% per patient-year); prosthesis thrombosis, 98.5% ± 0.7% (0.1% per patient-year); endocarditis, 97.2% ± 1.1% (0.4% per patient-year); prosthesis dysfunction, 97.1% ± 1.0% (0.4% per patient-year); hemolytic anemia, 98.5% ± 0.7% (0.1% per patient-year); reoperation, 97.4% ± 1.0% (0.4% per patient-year); overall mortality, 63.3% ± 2.7% (4.2% per patient-year); and valve-related death (including sudden death), 84.7% ± 2.2% (1.4% per patient-year). Independent preoperative risk factors were as follows: (1) for embolism, cardiac failure as indication for operation and history of prior systemic embolism; (2) for cerebrovascular accidents, the same two factors and age; (3) for endocarditis, diabetes, chronic alcoholism, and aortic valve replacement; (4) for overall mortality, age, ejection fraction (or cardiac index or cardiothoracic index), chronic alcoholism, and history of systemic embolism; and (5) for valve-related death, chronic alcoholism, degenerative cause of valve disease, and prosthetic diameter 23 mm or smaller. Ninety percent of survivors were in New York Heart Association functional class I or II at the end of follow-up. In conclusion, this study confirms the excellent durability of the St. Jude Medical valve and the remarkable functional benefit for the majority of the patients. However, prosthesis-related complications are still common, particularly for small-diameter prostheses. Outcome is strongly related to the patient's preoperative cardiac condition and to the adequacy of anticoagulation control(J Thorac Cardiovasc Surg 1997;113:134-48)

Long-term results of valve replacement with the St. Jude medical prosthesis: E.M. Baudet, V. Puel, J.T. McBride, J.-P. Grimaud, F. Roques, F. Clerc, X. Roques, N. Laborde, K.V. Arom. Department of Cardiovascular, Pediatric Cardiac Surgery, Haut-Leveque Heart Hospital, Bordeaux-Pessac, France. J Thorac Cardiovasc Surg 1995;109:858–70

Long-term results of valve replacement with the St. Jude medical prosthesis: E.M. Baudet, V. Puel, J.T. McBride, J.-P. Grimaud, F. Roques, F. Clerc, X. Roques, N. Laborde, K.V. Arom. Department of Cardiovascular, Pediatric Cardiac Surgery, Haut-Leveque Heart Hospital, Bordeaux-Pessac, France. J Thorac Cardiovasc Surg 1995;109:858–70

Long-Term Follow-up of the St. Jude Medical Prosthesis in Pediatric Patients

Background The St. Jude Medical prosthesis has become the most commonly used artificial heart valve, yet few data are available in the pediatric population. This study addresses results of the use of this prosthetic valve in pediatric patients over a 13-year time frame. Methods From January 1982 through June 1994, 73 patients (49 male) underwent 75 valve replacements using the St. Jude Medical prosthesis at Minneapolis Children's Medical Center. Follow-up was complete in 71 patients, with a mean follow-up of 39 ± 32 months (mean ± standard deviation; range, 4 to 142 months). Results Valves’ positions were aortic in 36 patients, mitral or left atrioventricular valve in 34, tricuspid in 1, and double valve in 2. Patient age was 8 ± 6 years, with a range of 1 week to 19 years. Sixteen patients were less than 24 months of age at valve replacement. Prior cardiac procedures had been performed in 82% of mitral patients, 58% of aortic patients, and all of the tricuspid and double-valve patients. Elective valve replacement was performed in 62 of 73 patients (85%). Seven patients (44%) less than 24 months of age had urgent valve replacement; 4 patients (7%) older than 24 months required urgent valve replacement. Overall early mortality was 8% (6 of 73); 36% (4 of 11) in the patients undergoing urgent valve replacement and 3% (2 of 62) in the elective group. All but one of the deaths were due to cardiac dysfunction. There were four late deaths, from 4 to 125 months postoperative, primarily caused by congestive heart failure or pulmonary vascular disease. Cumulative freedom from valve-related events was 93%, 85%, and 77% at 1, 5, and 10 years, respectively. Valve-related complications included thromboembolism (4), bleeding (5), perivalvar leak requiring reoperation (2), transient ischemic attack (1), and endocarditis (1). There have been no permanent strokes or mechanical malfunction. The majority of patients are currently managed with warfarin. Five surviving patients whose initial valve replacement was at age 24 months or younger have undergone repeat valve replacement (42%). Ninety-five percent of patients enjoy good health at follow-up. Conclusions The St. Jude Medical prosthesis offers correction of valvular disease with low morbidity and mortality, and excellent functional result. The St. Jude Medical prosthesis has become the most commonly used artificial heart valve, yet few data are available in the pediatric population. This study addresses results of the use of this prosthetic valve in pediatric patients over a 13-year time frame. From January 1982 through June 1994, 73 patients (49 male) underwent 75 valve replacements using the St. Jude Medical prosthesis at Minneapolis Children's Medical Center. Follow-up was complete in 71 patients, with a mean follow-up of 39 ± 32 months (mean ± standard deviation; range, 4 to 142 months). Valves’ positions were aortic in 36 patients, mitral or left atrioventricular valve in 34, tricuspid in 1, and double valve in 2. Patient age was 8 ± 6 years, with a range of 1 week to 19 years. Sixteen patients were less than 24 months of age at valve replacement. Prior cardiac procedures had been performed in 82% of mitral patients, 58% of aortic patients, and all of the tricuspid and double-valve patients. Elective valve replacement was performed in 62 of 73 patients (85%). Seven patients (44%) less than 24 months of age had urgent valve replacement; 4 patients (7%) older than 24 months required urgent valve replacement. Overall early mortality was 8% (6 of 73); 36% (4 of 11) in the patients undergoing urgent valve replacement and 3% (2 of 62) in the elective group. All but one of the deaths were due to cardiac dysfunction. There were four late deaths, from 4 to 125 months postoperative, primarily caused by congestive heart failure or pulmonary vascular disease. Cumulative freedom from valve-related events was 93%, 85%, and 77% at 1, 5, and 10 years, respectively. Valve-related complications included thromboembolism (4), bleeding (5), perivalvar leak requiring reoperation (2), transient ischemic attack (1), and endocarditis (1). There have been no permanent strokes or mechanical malfunction. The majority of patients are currently managed with warfarin. Five surviving patients whose initial valve replacement was at age 24 months or younger have undergone repeat valve replacement (42%). Ninety-five percent of patients enjoy good health at follow-up. The St. Jude Medical prosthesis offers correction of valvular disease with low morbidity and mortality, and excellent functional result.

Long-term follow-up of the St. Jude medical prosthesis in pediatric patients

The St. Jude Medical prosthesis has become the most commonly used artificial heart valve, yet few data are available in the pediatric population. This study addresses results of the use of this prosthetic valve in pediatric patients over a 13-year time frame. From January 1982 through June 1994, 73 patients (49 male) underwent 75 valve replacements using the St. Jude Medical prosthesis at Minneapolis Children's Medical Center. Follow-up was complete in 71 patients, with a mean follow-up of 39 +/- 32 months (mean +/- standard deviation; range, 4 to 142 months). Valves' positions were aortic in 36 patients, mitral or left atrioventricular valve in 34, tricuspid in 1, and double valve in 2. Patient age was 8 +/- 6 years, with a range of 1 week to 19 years. Sixteen patients were less than 24 months of age at valve replacement. Prior cardiac procedures had been performed in 82% of mitral patients, 58% of aortic patients, and all of the tricuspid and double-valve patients. Elective valve replacement was performed in 62 to 73 patients (85%). Seven patients (44%) less than 24 months of age had urgent valve replacement; 4 patients (7%) older than 24 months required urgent valve replacement. Overall early mortality was 8% (6 of 73); 36% (4 of 11) in the patients undergoing urgent valve replacement and 3% (2 of 62) in the elective group. All but one of the deaths were due to cardiac dysfunction. There were four late deaths, from 4 to 125 months postoperative, primarily caused by congestive heart failure or pulmonary vascular disease. Cumulative freedom from valve-related events was 93%, 85%, and 77% at 1, 5, and 10 years, respectively. Valve-related complications included thromboembolism (4), bleeding (5), perivalvar leak requiring reoperation (2), transient ischemic attack (1), and endocarditis (1). There have been no permanent strokes or mechanical malfunction. The majority of patients are currently managed with warfarin. Five surviving patients whose initial valve replacement was at age 24 months or younger have undergone repeat valve replacement (42%). Ninety-five percent of patients enjoy good health at follow-up. The St. Jude Medical prosthesis offers correction of valvular disease with low morbidity and mortality, and excellent functional result.

Doppler echocardiographic assessment with the continuity equation of St. Jude medical mechanical prostheses in the mitral valve position

Evaluation of the St. Jude Medical (SJM) valve in the mitral position with Doppler echocardiography has usually involved the use of gradients across the valve and the application of the pressure half-time (PHT) method to derive a mitral valve area. The purpose of this study was, first, to determine the normal values of effective orifice areas for the SJM valve in the mural position using the continuity equation, and second, to evaluate whether this parameter provides an improved assessment of valve function. Accordingly, Doppler echocardiography was performed in 40 patients within 6 weeks after valve replacement. All patients were clinically stable, without evidence of valvular dysfunction or aortic insufficiency. Valve size ranged from 23 to 33 mm and ventricular ejection fraction averaged 54 ± 13%. Effective orifice area was derived by the continuity equation using stroke volume measured in the ventricular outflow tract, divided by the time-velocity integral of the SJM valve jet, and by PHT. Doppler-derived SJM valve mean gradient averaged 4 ± 2 mm Hg. Effective area by the continuity equation averaged 1.82 ± 0.36 cm 2 (range 1.03 cm 2 for a 23 mm valve to 2.63 cm 2 for a 31 mm valve) and was smaller than by PHT (mean 3.10 ± 0.65 cm 2, p = 0.0001; range 1.38 to 4.78 cm 2). Areas by both methods were smaller than the actual valve orifice area provided b the manufacturer (4.53 ± 0.80 cm 2, p = 0.0001). With use of analysis of variance, effective SJM valve area by the continuity equation differentiated various valve sizes (p = 0.0002) better than did mean gradient (p = 0.013) or PHT (p = NS). Effective area by the continuity equation also correlated better with actual valve orifice area (r = 0.68, p <0.0001) than the area derived by PHT (r = 0.31, p = 0.06). Derivation of effective orifice area of SJM valves in the mitral position with the continuity equation allows better differentiation among valve sizes than mean gradients and PHT, and provides an additional index for assessing prosthetic mitral valve function.

Long-term results of valve replacement with the St. Jude Medical prosthesis

To assess with truly long follow-up the long-term results of valve replacement with the St. Jude Medical prosthesis (St. Jude Medical, Inc., St. Paul, Minn.), we reviewed the case histories of the first 1112 patients undergoing 1244 valve replacements with this valve between June 12, 1978, and June 12, 1987: 690 male (62%) and 422 female patients, mean age 56 years. A total of 773 patients (69%) had the aortic valve replaced, 207 (19%) the mitral valve, and 132 (12%) the aortic and mitral valves. There were 42 hospital deaths (3.8%). Follow-up was 97.5% complete (8988 patient-years). There were 213 late deaths. Ninety-one (43%) were considered valve-related: sudden death, n = 27; anticoagulant-related hemorrhage, n = 22; thromboembolism, n = 19; prosthetic valve endocarditis, n = 13; valve thrombosis, n = 9; and noninfectious perivalvular leak, n = 1. Overall actuarial survival, including hospital mortality, was 68% ± 6% (95% confidence limits) 14 years after the operation. Linearized rates of late valve-related events were as follows: thromboembolism, 1.09% per patient-year; anticoagulant-related hemorrhage, 0.94% per patient-year; prosthetic valve endocarditis, 0.32% per patient-year; valve thrombosis, 0.33% per patient-year; and perivalvular leak, 0.19% per patient-year. Actuarial freedom, at 14 years, from thromboembolism was 89% ± 3%, anticoagulant-related hemorrhage 83% ± 8%, valve thrombosis 97% ± 1%, and reoperation 95% ± 3%. Actuarial freedom from all valve-related deaths and valve-related morbidity and mortality, at 14 years, was 84% ± 6% and 61% ± 8%, respectively. We conclude that, because of its low thrombogenicity, low incidence of valve-related events, and low valve-related mortality, the St. Jude Medical valve is one of the best performing mechanical prosthesis currently available. Nevertheless, the late valve-related complications and deaths illustrate that the quest for a "perfect" prosthesis remains unfulfilled. (J T HORAC C ARDIOVASC S URG 1995;109:858-70)

Frequency of prosthetic valve-related complications with very low level warfarin anticoagulation combined with dipyridamole after valve replacement using St. Jude Medical prostheses

The safety of a very low level of anticoagulation combined with dipyridamole in a rheumatic population (mean age 31 ± 13 years) with the St. Jude Medical (SJM) prosthesis has not yet been tested. Furthermore, no data are available on the safety of relatively infrequent monitoring of anticoagulation levels and of the necessity for different therapeutic targets according to valve position, number of risk factors, and other baseline risk factors for thromboembolism. In this study, the performance of the SJM prosthesis was tested using a target international normalized ratio (INR) of 2.0 to 2.5 combined with dipyridamole 300 mg/day applied uniformly to all patients. Clinical, biochemical, and echocardiographic data were acquired prospectively in 200 consecutive patients at 3-month intervals. Follow-up (mean 27 ± 13 months) was complete in 95% of patients. Thirteen patients died (2.9%/ patient year). Severe left ventricular dysfunction was the cause of death in 10 of 13 patients. Probability of survival (Kaplan-Meier) was 0.92 at 36 months and of event-free survival 0.84 at 36 months. The median INR was 2.0 ± 0.9. Valve obstruction did not occur, and there were 3 thromboembolic events (0.6%/patient year). Incidence of bleeding was 1.6%/patient year (n = 7) and was major (hemorrhagic stroke) in 1 (0.2%/ patient year). Thus, the SJM prosthesis performs very well despite the use of very low level warfarin anticoagulation combined with dipyridamole. A 3-month assessment of the anticoagulation level is safe. Left ventricular dysfunction rather than valve-related complications is the leading cause of mortality in this population.

Tricuspid valve replacement with the bileaflet St. Jude Medical valve prosthesis

Case histories of 39 patients who underwent tricuspid valve replacement with the St. Jude Medical prosthesis between June 1979 and August 1992 were reviewed in March 1993. The average patient age at the time of the operation was 46 +/- 11 years (range from 17 to 68 years). Concomitant mitral and/or aortic valve replacements were performed in 30 patients. All patients were given warfarin to maintain thrombotest between 10% to 25%. This number was between 2.8 to 1.6 times the control value in the International Normalized Ratio of prothrombin time. Three operative deaths occurred (7.7%). Among six late deaths, two patients died suddenly of unknown causes, and the remaining patient deaths were not valve-related. The actuarial survival rate at 14 years was 54.7%. Valve thrombosis occurred in one patient and was successfully treated with intravenous urokinase. This was the only valve-related complication (0.67%/patient-year). No reoperations were necessary in the tricuspid position. In conclusion, the St. Jude Medical valve is our choice of prosthesis for tricuspid valve replacement in adult patients who can receive proper anticoagulation therapy.

The St. Jude Medical prosthesis: A thirteen-year experience

From May 1979 until July 1992, 1184 patients, 2 to 86 years of age (median = 59 years), received 1367 St. Jude Medical prostheses (578 aortic, 440 mitral, 3 tricuspid, and 170 multiple). Overall early mortality was 4% with 2.4%, 4.3%, and 8.2% after aortic, mitral and multiple valve replacement, respectively. Follow-up was 100% complete (4936 patient-years). Actuarial survival at 10 years (including both early and late deaths) was 71% ± 4.1% after aortic valve replacement, 58.8% ± 5.1% after mitral valve replacement, and 58.9% ± 9.6% after multiple valve replacement. Multivariate analysis identified age, previous operations, diabetes mellitus, extent of coronary artery disease, preoperative New York Heart Association class, and additional procedures as independent prognostic factors for overall survival. All patients including 20 children (2 to 18 years of age) received sodium warfarin. The linearized risk per 100 patient-years for all embolic events (major and minor) was 2.4, 4.4, and 5.0 after aortic, mitral, and multiple valve replacement, respectively; when only major events were considered, the linearized risks were 0.33, 1.17, 1.54, respectively. Freedom from major systemic embolism at 10 years was 96% ± 2% after aortic valve replacement, 88% ± 4% after mitral valve replacement, and 89% ± 3% after multiple valve replacement. Five patients had valve thrombosis, four of whom definitely received inadequate anticoagulation therapy. Ninety-seven patients had 107 episodes of anticoagulant-related hemorrhage (2.2/100 patient-years) accounting for 17 late deaths; 14 of the deaths involved an international normalized ratio in excess of 3.5. To reduce the rate of thromboembolism without increasing the rate of anticoagulant-related hemorrhage, we propose that the international normalized ratio should be kept between 2.5 and 3.0. No recorded structural failure or significant hemolysis was found in the absence of periprosthetic leak. This experience encourages us to continue using the St. Jude Medical prosthesis. (J THORAC CARDIOVASC SURG 1994;108:221-30)

St. Jude Medical prosthesis in children

From December 1980 through April 1992, 20 children 2 to 18 years of age underwent valve replacement with the St. Jude Medical prosthesis. Nine children underwent aortic valve replacement, eight underwent mitral valve replacement, and the three children with corrected transposition underwent left-sided tricuspid valve replacement. Of the 20 patients, 17 underwent 23 previous procedures. All but five patients received adequate adult-sized prostheses. There was one hospital death (5%). All hospital survivors received maintenance doses of sodium warfarin. Follow-up was 100% complete with a total of 106 patient-years. There were no late deaths and no thromboembolic or anticoagulant-related bleeding. None of the patients had prosthetic valve endocarditis or a periprosthetic leak. Reoperation was not required in any patient. The great majority of the children (16 of 19) were in New York Heart Association functional class I, two were in class II, and one with complex congenital heart disease was in class III at the time this article was written. This study illustrates the excellent results of cardiac valve replacement with the St. Jude Medical prosthesis in children and confirms the safety of sodium warfarin in this age group. (J THORAC CARDIOVASC SURG 1994;108;52-6)

Lower intensity anticoagulation therapy results in lower complication rates with the St. Jude Medical prosthesis

Six hundred consecutive patients were operated on between September 1978 and October 1982 for isolated aortic (n = 298), mitral (n = 215), or multiple valve replacement (n = 87) with the St. Jude Medical bileaflet prosthesis. Mean age of the 303 female and 297 male patients was 50.7 +/- 9.6 (range 12 to 83) years. All patients were followed up prospectively; follow-up was complete and averaged 122.2 +/- 1.1 months for operative survivors. Total follow-up for aortic patients was 2904.1 patient-years, for mitral replacement 1859.5 patient-years, and for multiple valve replacement 736 patient-years. When the prothrombin times measured with different thromboplastins were converted into an international normalized ratio, four patient groups could be separated; that is, the groups comprised patients whose anticoagulation was maintained during the follow-up within an international normalized ratio corridor of 4.0 to 6.0, 3.0 to 4.5, 2.5 to 3.5, or 1.75 to 2.75. Less intensive anticoagulation in terms of the international normalized ratio values caused only a mild increase in the incidence of thromboembolic complications but a highly significant decrease in the rate of bleeding. Severe bleeding complications in the aortic valve group were highest with an international normalized ratio of 4.0 to 6.0 (1.15 per patient-year) and lowest with an international normalized ratio of 1.75 to 2.75 (0.24 per patient-year). The same held true for patients with single St. Jude Medical mitral valve replacement (2.09 per patient-year versus 0.72 per patient-year) and multiple valve replacements (4.45 per patient-year versus 1.20 per patient-year). These results suggest that the generally recommended international normalized ratio of 3.0 to 4.5 may be too high for patients with St. Jude Medical aortic valve replacement and also for patients with St. Jude Medical prostheses in the mitral position if, with respect to the thromboembolic hazard, there is not a predominating patient-related comorbidity. A large multicenter prospective randomized study is therefore proposed to establish the safe international normalized ratio levels accompanied by the lowest complication rates for both bleeding and thromboembolic events after St. Jude Medical prosthesis implantation (German experience with low intensity anticoagulation study).

Twelve years' experience with the St. Jude Medical valve prosthesis

Since July 1978, 1,284 patients have received the St. Jude Medical prosthesis (425 aortic, 636 mitral, and 223 double aortic-mitral), and the results in these patients were reviewed according to guidelines of the Society of Thoracic Surgeons. Follow-up was complete in 98%. Of 80 late deaths, 29% were valve related. The actuarial survival rate, including operative deaths, at 12 years was 81.7% and 87.1%, respectively, for aortic and mitral valve replacement, and it was 82.6% at 11 years after double valve replacement. All patients were anticoagulated with warfarin to maintain the thrombotest value between 10% and 25%, which is equivalent to between 2.8 and 1.6 times the control according to the international normalized ratio of the prothrombin time. The linearized rate of complication for aortic, mitral, and double valve replacement, respectively (expressed as the percent per patient-year), was as follows: structural deterioration, 0; nonstructural dysfunction, 0.16, 0.30, and 0.20; valve thrombosis, 0.05, 0.09, and 0; thromboembolism, 1.35, 1.63, and 0.79; anticoagulant-related hemorrhage, 0.10, 0.18, and 0.10; and prosthetic valve endocarditis, 0.21, 0.06, and 0.20. Reoperation was performed in 16 patients. The freedom from reoperation rate at 12 years was 99.5% and 98.0% for aortic and mitral valve replacement, respectively, and it was 99.1% at 11 years for double valve replacement. Thus, during the 12-year follow-up in patients who received the St. Jude Medical prosthesis, the valve performed satisfactorily and with an acceptable risk of late complication even though patients were anticoagulated using a lower dose of warfarin.

Early and late-phase events after valve replacement with the St. Jude Medical prosthesis in 1200 patients

From May 1982 to August 1991, 1200 patients underwent valve replacement with the St. Jude Medical (St. Jude Medical, Inc., St. Paul, Minn.) valve: 615 men (51%) and 585 women, mean age 58 years. Preoperatively, 830 patients (69%) were in functional class III or IV. A total of 611 patients (51%) had the aortic valve replaced, 490 (41%) the mitral valve, 2 (0.2%) the tricuspid valve, and 97 (8%) multiple valves. There were 81 hospital deaths (6.8%). Risk factors included older age (p = 0.0001), female gender (p = 0.02), higher preoperative left ventricular end-diastolic pressure (p = 0.05), previous cardiac operation (p = 0.003), longer aortic crossclamp time (p = 0.0001), and longer cardiopulmonary bypass time (p = 0.0001). Follow-up was 98% complete (3153 patient-years). There were 152 late deaths; 32 (21%) were considered valve-related: six thromboembolism, four valve thrombosis, five anticoagulant-related hemorrhage, eight prosthetic valve endocarditis, one paravalvular leak, and seven sudden death. The 5-year actuarial survival was 75%. Risk factors for late death included older age (p = 0.03), lower preoperative ejection fraction (p = 0.005), longer aortic crossclamp time (p = 0.001), longer cardiopulmonary bypass time (p = 0.0001), previous cardiac operation (p = 0.02), and higher preoperative functional class (p = 0.0001). Actuarial freedom at 5 years from major thromboembolic events and anticoagulant-related hemorrhage was 97% and 95%, respectively. This value for valve thrombosis was 99%, for reoperation 96%, for prosthetic valve endocarditis 98%, and for paravalvular leak 96%. Actuarial freedom from all valve-related events and valve-related death at 5 years was 74% and 94%, respectively. We conclude that the low incidence of valve-related events and low mortality supports the continued use of the St. Jude Medical valve.

The St. Jude medical prosthesis in the mitral position.

To study the long-term results of the St. Jude medical prosthesis in the mitral position, 520 patients were evaluated who had undergone mitral valve replacement with St. Jude medical (SJM) prosthesis. Eighteen patients or 3.5% died in the early postoperative period (within 30 days after operation). The total follow-up was 2872 patient-years and late deaths occurred in 23 cases. Postoperative cerebral embolism occurred in six, bleeding complication in five, and thrombosed valve in two patients. Postoperative anti-coagulant therapy was initiated with both dipyridamole (300 mg/day) and warfarin potassium. After discharge from our hospital the patients underwent routine examination of their thrombo-tests or prothrombin times at least every 2-3 months, and the major thromboembolic or bleeding complication rate was 0.45%/100 patient-years. In a period of 12 years, severe hemolysis following implantation was seen in seven patients. The cause of this hemolysis was perivalvular leakage in two patients but there were no leakages in the other five patients, although preoperative moderate to severe liver dysfunction was noted. Ninety-three percent of the patients were followed up, and their postoperative New York Heart Association functional classes were I or II in 88.6% of the cases. Their clinical results after mitral valve replacement with SJM prosthesis in the anti-anatomical position showed excellent durability and a low incidence of valve-related complications.

Aneurysm of the atrioventricular septum between the left ventricle and right atrium without septal defect

partly separated this layer from the thinned outer muscular wall, which had ruptured at a point close to the left superior pulmonary vein. There was a large hematoma at this site that had presumably not progressed to full-blown tamponade because of the presence of pericardial adhesions. No intracardiac thrombus was evident. The left atria1 dissection was repaired and the Carpentier-Edwards xenograft was excised and was replaced with a 31 mm St. Jude Medical prosthesis (St. Jude Medical, Inc., St. Paul, Minn.). Postoperatively the patient remained extremely ill and she died in cardiogenic shock 36 hours later. Consent for a postmortem examination was refused by her family. Pulmonary edema in patients with mitral valve prostheses is usually caused by thrombotic occlusion of mechanical prostheses,’ ball valve thrombotic occlusion of the mitral anulus, acute degeneration of bioprostheses,2 acute arrhythmias, or poor left ventricular function as a result of associated coronary artery disease or coronary embolism. All these syndromes result in acute elevation of left atria1 pressure. In contrast, left atrial dissection may result in pulmonary edema caused by compression of the pulmonary veins and elevation of pulmonary venous pressure without increased left atria1 pressure. We suggest that this possibility be borne in mind in the differential diagnosis if a patient presenting with pulmonary edema appears to have satisfactory mitral valve function. Transesophageal echocardiography, although not performed in this instance, should be useful in assessing such patients. REFERENCES

Left atrial plication and mitral valve replacement for giant left atrium accompanying mitral lesion.

Between January 1982 and November 1992, 38 patients received simultaneous mitral valve replacement (MVR) and left atrial plication (LAP) because of giant left atrium accompanying mitral lesion. Their ages ranged from 33 to 70 years, and the mitral lesion was caused by rheumatic heart disease in all patients. MVR was performed with a St. Jude Medical prosthesis for all patients and the left atrial wall was plicated with running 3-0 Nespolene to reduce the width to 3 to 5 cm. Respiration requiring mechanical ventilation more than 48 hours after operation occurred in four patients (10.5%) and postoperative low cardiac output requiring a high dose of dopamine HCl or intraaortic balloon pumping in nine patients (23.7%). The left atrial diameter measured by echocardiogram was a mean of 7.3 +/- 1.0 cm before operation and 5.8 +/- 1.0 cm postoperatively. The cardiothoracic ratio on the chest roentgenogram registered a preoperative mean of 73.3% +/- 9.8% and was 65.7% +/- 8.4% after operation. The pre- and postoperative values were significantly different (p < 0.01). The postoperative exercise level was a mean of 5.3 metabolic units for 24 patients and the postoperative New York Heart Association functional classification indicated Class I or II for 37 patients with no evidence of left atrial thrombus except in the case of one early death. LAP with MVR for patients with giant left atrium due to mitral lesion appeared to result in improvement in respiratory and circulatory functions.

Frequency and severity of intravascular hemolysis after left-sided cardiac valve replacement with medtronic hall and St. Jude medical prostheses, and influence of prosthetic type, position, size and number

Intravascular hemolysis occurs often in patients with mechanical heart valve prostheses, but in most cases is of mild degree and subclinical. The severity of hemolysis is reported to be related to the type, position and size of prostheses used, as well as the presence of valve malfunction. Hemolysis was evaluated in 170 patients with St. Jude Medical (SJM) and 80 patients with Medtronic Hall (MH) prostheses, with normal mechanical function. The presence and severity of hemolysis was assessed on the basis of serum lactic dehydrogenase, serum haptoglobin, blood hemoglobin and reticulocyte levels as well as the presence of schistocytes. Overall, patients with SJM prostheses had greater frequency (51.2 vs 18.7%, p < 0.005) and severity (p < 0.005) of hemolysis than patients with MH prostheses, irrespective of position and size. No patient had decompensated anemia. The frequency of hemolysis was similar in both groups with double-valve replacement, whereas severity was greater with SJM than MH prostheses (p < 0.001). The number and position of the prostheses were correlated with severity of hemolysis: Double-valve replacement and mitral position were correlated with greater hemolysis than single-valve replacement (p < 0.01) and aortic position (p < 0.01). Valve size, cardiac rhythm and time from operation did not correlate either with frequency or severity of hemolysis. It is concluded that in normally functioning SJM and MH prostheses (1) hemolysis is frequent but never severe; (2) SJM demonstrates greater frequency and severity when compared with MH valve; and (3) number, position, but not size, significantly affect the severity of hemolysis.

Antithrombotic Therapy in Patients With Mechanical and Biological Prosthetic Heart Valves

Antithrombotic Therapy in Patients With Mechanical and Biological Prosthetic Heart Valves